DARPARA2601.pdf

DARPARA2601

Research Announcement for

Protean

Biological Technologies Office

DARPARA2601

February 11th, 2026

This Research Announcement (RA) constitutes a public notice of a competitive funding opportunity as described in 2 CFR § 200.203. Any resultant negotiations and/or awards will follow all laws and regulations applicable to the specific award instrument(s) available under this RA.

Table of Contents

1. Overview Information

2. Funding Opportunity Description

3 Submission Information

3.5 General Guidelines

4. Special Considerations

ATTACHMENTS:

ATTACHMENT 1: PROPOSAL TEMPLATE – VIDEO ABSTRACTS

ATTACHMENT 2: PROPOSAL TEMPLATE – ABBREVIATED TECHNICAL VOLUME

ATTACHMENT 3: S&T PROTECTION IMPLEMENTATION PLAN (PIP) TEMPLATE

ATTACHMENT 4: PROTEAN CUI GUIDE

1. Overview Information Federal Agency Name – Defense Advanced Research Projects Agency (DARPA), Biological Technologies Office (BTO) Funding Opportunity Title – Protean Announcement Type – Initial Announcement Funding Opportunity Number – DARPARA2601 NAICS Code: 541714 Dates:

o Posting Date: February 11th, 2026 o Protean Virtual Proposers Day: February 20th, 2026 o Question Submittal Closed: March 9th, 2026 by 4:00 PM ET o Gate 1 Due Date (Abstract): March 12th, 2026 by 4:00 PM ET o Gate 2 Due Date (Full Proposal): May 7th, 2026 by 4:00 PM ET

Concise description of the funding opportunity:

This Research Announcement represents a solicitation for a research thrust, entitled Protean, that will focus on identifying novel ways to restore protein function to targets of chemical threat agents.

Anticipated individual awards – Multiple awards may be awarded.

Types of instruments that may be awarded – Cooperative Agreements and Research

Other Transactions Awards.

Agency contact

Technical POC: Michael Feasel, Ph.D., Program Manager, DARPA/BTO o Agreements/Grants Officer: Ms. Katie Freeman, DARPA/CMO o Email: ProteanTherapeutics@darpa.mil o Mailing Address:

DARPA/BTO

ATTN: DARPARA2601

675 N. Randolph Street Arlington, VA 22203-1714 mailto:ProteanTherapeutics@darpa.mil

2. Funding Opportunity Description

2.1 Introduction

The Defense Advanced Research Projects Agency (DARPA) is soliciting innovative proposals for the design of medical countermeasures (MCMs) that provide complete protection against current and future chemical threats. The following sections of this solicitation will (1) identify specific details regarding the research topic of interest, including the technical goals and metrics; and (2) provide proposal content and submission instructions, including the due date for proposal submissions. Proposals submitted in response to Protean will be evaluated and selected in accordance with Section 3 of this RA.

2.1.1 Protean Overview:

The prevention and treatment of chemical exposure on the battlefield have primarily relied on MOPP (mission oriented protective posture) gear as a physical barrier, and symptom control following exposure. Such countermeasures rely on expedient transport of exposed warfighters to highly equipped medical facilities so that the casualty can outlast the agent. In future theaters of war, where transport is unavailable or in cases where the physical seal of MOPP gear is broken, more effective medical interventions are required to maintain life and limb.

Beyond the logistical challenges associated with the treatment of chemical exposure, the list of potential chemical threat agents is rapidly outpacing the rate at which specific interventions are designed and approved for human use. The current threat space of >10 million chemical entities is continuing to grow, highlighting an incompatibility with the design of countermeasures against each individual threat. However, the number of unique human proteins that are impacted by these threat agents remains the same. MCMs that treat the root cause of intoxication at the protein level have the potential to render entire threat-classes “non-toxic”. Resolving chemical exposure at the mechanistic level could therefore dramatically reduce the number of interventions required to provide complete protection to the warfighter.

MCM design has plateaued in the last three decades, in part, due to limited insight as to how protein function can be maintained or restored in the presence of a given threat. Protean hypothesizes that the key to overcoming this hurdle lies in elucidating the structure, dynamics, and binding pockets that regulate protein function. Emerging structural biology and modeling approaches have recently enabled accurate characterization of proteins as they move through time and space. These molecular motions occur on timescales spanning femtosecond to milliseconds and are the underlying drivers of a given protein’s function. Great diversity in these motions exist across the human proteome, however, the Protean program will focus on the three specific protein targets that are most commonly impacted by chemical agents: Acetylcholinesterase, Mu Opioid Receptor and ion channels. By the end of the program, it is envisioned that performers will produce novel interventions that provide significantly improved protection against chemical threats of a given class.

Protean Goal: Develop prophylactics (and optionally therapeutics) that protect protein function against chemical threat challenges over 10,000x LD50s.

Successful proposals must provide the following:

1. An approach for discovering novel regulatory points for proposer’s selected protein target.

2. Methods for characterizing the mechanism of chemical intoxication for at least 1 class of threats or surrogates/simulants. Interventions must provide broad protection against chemical threats that share a mechanism of action.

3. Methods for evaluating whether a given protein conformation, binding site or dynamic event contributes to protein function.

4. A well-integrated pipeline for optimization of chemical matter to achieve end-of-program efficacy metrics in vivo.

Specifically excluded are proposals that involve:

1. Strategies that exclusively develop competitive inhibitors or activators.

2. Strategies designed to absorb or degrade a specific chemical threat, e.g. agent-centric sponges and detoxifying enzymes.

3. Medical countermeasure development that relies on genetic engineering of the host as an intervention.

4. Research that generates incremental improvements to existing MCMs including but not limited to: analogs, formulation, delivery systems.

5. Molecular design strategies that lack novel mechanistic insight. NOTE: This includes proposals that rely entirely on black box AI/ML strategies where the internal model structures are unknown or difficult to interpret.

2.2 Anticipated Structure:

The Protean program is divided into two sequential Phases totaling 33 months, with Phase 1 (Base) being 18 months and Phase 2 (Option) being 15 months. Phase 1 consists of three different focus areas (FAs) based on threat class of interest: 1) nerve agents, 2) synthetic opioids, 3) and ion channel toxins. Performers may propose work that supports one or multiple FAs but must propose to both phases. An evaluation of technical progress will occur continuously throughout the phase, with successful fulfilment of the 16-month milestone and all intermediate metrics being required for progression into Phase 2.

Proposals that fail to address both Phases will be deemed non-conforming and not considered for review.

Figure 2.2. Program Schedule. FA: Focus Area, T&E: Test and Evaluation, LD50: Lethal Dose, 50%, CB: Chemical and Biological, MCMs: Medical Countermeasures

2.2.1 Phase 1 – Non-classical Protection

The goal of Phase 1 is to identify novel intervention points within the conformational landscape of a target that protect against future threat agent attack (prophylactics) or allow for the restoration of functionality (reversal agent) to restore function. These intervention points may be found within the conformational landscape of a single protein target, at the interface of multi-protein complexes i.e. protein-protein interactions (PPI), or within broader signaling cascades (e.g., GPCRs or other protein cascades). The molecular mechanisms by which chemical threats impact protein function, and how these events lead to physiological collapse are currently underdeveloped. Beyond a simple understanding of binding sites, affinities, and rates, lie the dynamic and conformational changes that dictate how a chemically bound and unbound protein moves and functions, and beyond that, how those initiating interactions lead to deterioration of physiological function. It is through these motions, rearrangements, and PPIs that proteins carry out their physiological role, and a greater understanding is therefore required to identify 1) which motions are impacted by a chemical threat 2) which protein conformations are stabilized/destabilized, and 3) if unappreciated events impacting substrate-protein, ligand-protein, or protein-protein interactions occurring at rapid timescales (fs-µs) and rare fleeting events hold information that can be leveraged to protect or restore function. To this end, it is anticipated that performers will capture and model the conformational trajectories of their bound and unbound target protein, identify differences in single- or multi-protein mechanisms, and leverage molecular approaches to evaluate the contributions of novel states to a given adverse outcome pathway or pathology.

Work under this Phase will require performers to select a DoD-relevant protein that is a direct target of a chemical threat or one or more that are critical for the intended outcome of the toxicant from one of the three focus areas: 1) nerve agents, 2) synthetic opioids, and 3) ion channel toxins.

Performers are expected to either work on a surrogate of a known chemical threat (e.g.

organophosphate-based pesticides vs. sarin, or VX) or directly on a chemical warfare agent itself, if containment strategies and handling restrictions can be appropriately addressed by the proposing institution. Considerations for chemical threat or simulant selection may include mechanistic relevance for both known and future chemical threats, tractability for structural biology approaches, and relevance to commercial transition opportunity. Throughout the phase the performer is expected to provide proof of concept for preventing chemical agent intoxication and alteration of protein function. It is expected that this will require an advanced understanding of threat agent binding, downstream conformational changes, binding site availability and associated signaling events. Further, performers must provide a systematic exploration of ways to intervene in this process, while maintaining binding and downstream activity associated with endogenous ligand(s). Mechanisms elucidated in Phase 1 using simulant chemical compounds must translate to a real chemical warfare agent (CWA). The end of Phase 1 validation (in vitro) and the end of program validation (in vivo) will be class/target specific. Initial structural biology and modeling studies may be performed on multiple proteins to capture the deleterious effects associated with the binding of alternative proteins, but the selection of each testbed must be technically justified.

Phase 1 efforts will culminate in an in vitro demonstration that the function of a chemically compromised protein, can be protected or restored by rational intervention. Within this demonstration, any molecular tool may be leveraged, and mature drug-compounds need not be applied. End of phase validation tests with real CWAs will be performed by a government test and evaluation (T&E) partner in both phases. Successful completion of this demonstration is required to progress into Phase 2 of the program where intervention design and optimization of function are primary thrusts.

2.2.2 Phase 2 – Countermeasure Design

The primary goal of Phase 2 is to advance design capabilities to generate safe and efficacies compounds that either protect or restore function in a protein target in the presence of a CWA.

Teams must optimize drug-like properties such that dramatically greater protection is achieved in vivo compared to state-of-the-art MCMs.

Work under this Phase will require performers to focus on identifying and generating chemical matter that acts through the non-competitive sites identified in Phase 1. A successful proposal may include approaches that fall within structure-based drug design and/ or ligand-based drug design and can be either computational or experimental in nature. Throughout the Phase, it is expected that compounds will increase in efficacy in vitro and will be initially tested in vivo by Protean’s T&E partner at 24 months (See table 2.3.1). Pharmacokinetic and pharmacodynamic evaluation of lead drug molecules must be established prior to the end of Phase but can include in silico capabilities to accelerate drug optimization prior to testing in animals.

Phase 2 efforts will culminate in an in vivo demonstration carried out by a government T&E partner with real CWAs (Month 33). Physiological protection will be evaluated via multiple endpoints to ensure that compounds developed under this program provide functional rescue in an animal. In the last 3 months of program, performers will work closely with the T&E organization to provide materials, protocols, and preliminary data required for safe and expedient execution of these studies. Engagement between T&E and performer groups is expected to happen starting at month

12 of the program and will be ongoing throughout the end of Phase 1 and all of Phase 2. Performer molecules will not be tested in an in vivo chemical-threat challenge model if the compounds fail to provide ample evidence of efficacy, safety and acceptable absorption, distribution, metabolization and excretion (ADME) properties.

2.3 Program Metrics, Milestones and Deliverables:

Performers must propose specific deliverables (report, data, product, prototype, etc.) that demonstrate completion of a milestone or metric. The content of each deliverable will vary from task to task but must be designed such that the Government can evaluate performer progress towards the end goals of the program.

Table 2.3.1 RA Metrics and Milestones

Metrics and Milestones for all Focus Areas

Phase 1:

6 Months – Characterize the energetics, kinetics, and mechanisms and validate how each event impacts function.

- E.g., Allosteric binding events, cryptic binding site identification, protein dynamics regulatory events, identification of alternate control surfaces

- Identify >1 novel distal regulatory sites or modes of regulation within protein target of interest.

12 Months – Demonstrate a >10-fold decrease in threat simulant binding affinity for its protein target, while ensuring endogenous ligand/substrate binding is minimally impacted (<5x, across all target classes) 16 Months - Restore or prevent loss of function of a chemically-impacted protein.

- Rescue or protection: >10x increase in *ED50 of >3 threat surrogates/simulants for target-specific in vitro endpoint.

End of Phase Milestone – 18 Months: T&E will evaluate in vitro efficacy on >3 class specific chemical threats.

Phase 2:

24 Months – Demonstrate in vitro protection of function to a protein via molecular intervention: 1,000x increase in threat simulant ED50 for in vitro endpoint

- Lack of acute toxicity predicted by in vitro ADR panel.

Mid Phase 2 Milestone - 24 Months: (T&E) LD50 of chemical threat with intervention is >1000x baseline exposure in a rodent model 30 Months – End of program Milestone – Optimized lead compound

- Half-life of intervention ≥ threat agent compound or target-threat adduct.

- Prevention of threat agent initiated signaling events in vitro: 10,000x increase in threat simulant ED50 for in vitro endpoint

End of Program Milestone - 33 Months: (T&E) Demonstrate intervention relieves physiological outcomes of chemical threat exposure in a rodent model.

- LD50 with intervention is >10,000x baseline exposure

ADR: Adverse Drug Reaction, ED50: effective dose, 50%

Protein-associated dynamics span multiple orders of magnitude, be it femtosecond vibrations of atoms, picosecond side chain motions, nanosecond active site dynamics or micro/ millisecond domain motions. Within these broad temporal categories, not all events impact activity equally.

Many of these events may be energetically linked (e.g., larger domain motions comprised of, or initiated by, faster timescale events), yet an understanding of these relationships may or may not be necessary to aid MCM design. Accordingly, the states, motions and novel regulatory sites identified towards the 6-month milestone are to be provided in a rank-ordered list and prioritized for downstream validation and MCM design compatibility (e.g., ease of manipulation, or likelihood of energetic linkage to established orthosteric / allosteric sites, etc.)

It is envisioned that performers will use a combination of structural biology and computational techniques to characterize Phase 1 protein targets. While advances in molecular dynamics simulation and structure prediction models have enabled rapid and cost-effective predictions of protein dynamics, it is expected that novel events and protein states be experimentally validated to achieve the month 12 milestone.

Lead optimization strategies are expected to be target-specific in Phase 2, and success will be stringently evaluated by functional rescue of protein activity throughout the Phase (in vitro). Prior to evaluation of molecules against a threat agent in vivo by T&E partners, performers must demonstrate safety and efficacy metrics by month 30. Additional advances in formulation, optimization and materials transfer to T&E are expected to happen between month 30 and 33 to support timely delivery of end of program deliverables.

3 Submission Information

3.1 Acquisition Strategy Overview

The government's aim is to lower the administrative burden to entry, reduce program risk, foster competition, and have performing teams begin their work faster. To facilitate this objective, the government will use the following acquisition process for Protean:

Gate 1 Submissions:

a. Video Abstract Due - March 12th, 2026

Video abstracts are intended to provide an overview of the value a proposer brings to the Protean Program. At this stage, proposers must demonstrate an understanding of Protean’s technical challenge, and provide an approach to address it, but are not required to pick a specific focus area.

Selection of focus area(s) for a given proposal will be finalized at the full proposal stage. NOTE:

No budget information should be included in the video abstract. Video Abstracts are to be no more than 10 minutes in length and are highly recommended to include a visual component. Audio/video files and Presentation Slides must be submitted at the controlled unclassified information (CUI) or UNCLASSIFIED level. The Protean CUI guide is included as Attachment 4 to this solicitation.

The government will review all submitted video abstracts according to the evaluation criteria in RA (see Section 3.3).

b. Abbreviated Technical Volume Due - March 12th, 2026 Abbreviated technical volumes are required to be submitted with an associated video abstract.

Submissions containing only one of these items will not be reviewed. The abbreviated technical volume will be reviewed by the scientific review board in conjunction with the video abstract.

Abbreviated Technical Volumes meeting the criteria in Section 3.3 may be invited to provide a written full proposal to the government if selected by the review board (Section 3.4). Selection letters will be provided to proposers after gate 1 review and will specify who will proceed to the full proposal stage. If DARPA does not invite the proposer to submit a full proposal, DARPA will provide feedback to the proposer regarding the rationale for this decision.

Gate 2 Submissions:

Due May 7th, 2026 If a proposal passes Gate 1, the Government may request additional technical support, budget support, or administrative clarification to support negotiations. For the purposes of competition, proposers at this stage are considered post-competitive. Additional proposal instruction and detailed submission timelines will be provided by the Government team upon selection. Proposers selected at this stage will be invited to a pre-award feedback session prior to the full proposal due date.

Feedback Session (invitation only): Proposers who are selected for full proposals will be invited to participate in a feedback session with the Protean program manager. This session will provide an early opportunity to discuss and refine the scope of proposals prior to final submission deadline.

Additional details for the event will be provided with selection letters following Gate 1.

Participation from the proposing organization is highly encouraged.

In response to this RA, Video Abstracts, Abbreviated Proposals, and Full Proposals submitted after the respective due dates may not be considered by DARPA. The government will not pay proposers responding to this RA for the costs associated with abstract submissions or proposal submissions.

3.2 ‘Gate 1’ Submission Information

(Gate 1) Video Abstracts Video abstracts and supporting Presentation Slides are to be submitted at the UNCLASSIFIED or CUI level. No classified information will be accepted. Only one (1) technical solution may be presented per Proposer to Abstract Gate 1.

Video presentations should be no more than 10 minutes and cover the following content:

Two (2) slides describing the technical approach to the Protean program challenge

One (1) slide describing the innovation relative to state-of-the-art

One (1) slide depicting relevance to the DARPA mission

One (1) slide introduction of the proposing team and key personnel Virtual presentation slides are subject to the following constraints:

There should be no more than 5 slides. The title page and slides listing references will not count against the slide limit.

No smaller than 12-point font

Video demonstrations are allowed

All material and additional required artifacts are to be submitted to DARPA’s BAAT website:

(https://baa.darpa.mil) by the due date on page 3.

(Gate 1) Abbreviated Technical Volume:

Written proposals at this stage should not exceed five (5) single-sided 8.5” by 11” written pages using 12-point Times New Roman font with 1” margins all around. Footnotes and text inside of graphics are not required to be 12-point font but must be legible.

The abbreviated technical volume must include the following clearly labeled sections:

a) Cover Sheet (does not contribute to page limit): Proposer Organization, Abstract Title, Technical Point of Contact Name, E-Mail Address, Phone, Address, and CAGE Code (Optional).

The proposer shall include a statement that no personnel on the proposer's team are also working for DARPA as Systems Engineering Technical Assistance (SETA), Advisory and Assistance Services (A&AS), or similar support services, as DARPA has a policy prohibiting such people from working as a technical performer. Include this statement on the Cover sheet page; it will NOT count as part of the written page limit. Refer to Section 4.3 for additional eligibility requirements.

b) Executive Summary (1 page): The executive summary is intended to introduce the proposal to each government participant on the scientific review board. This section is to include each of the following items: i) Primary goal of the proposal, ii) Relation of proposed strategy to current state-of-the-art, iii) DoD Impact/ National Security Relevance, and iv) Innovation. The length of each subsection is up to the proposer but should ultimately attempt to best summarize the value of the proposal to a reviewer.

c) Technical Approach (2.5 pages to 3 pages): Demonstrate an understanding of the specific technical challenges faced in Protean. Proposers need not restrict their proposal to a specific protein target or focus area at this stage. The intent of this section is to demonstrate where a given strategy can provide maximal value to the overall program goals.

The proposer should provide details of the anticipated work to achieve Protean objectives and detail technical risks. Risk mitigation strategies are appropriate to include if deemed necessary by the proposer but are not required until submission of full proposal. The proposer should not include previously achieved capabilities in this section.

d) Technical Ability (0.5 page to 1 page): Detail the proposer’s team and organization and explain the ability to be successful at achieving the goals, if selected, for Protean. The proposer may include past experience, organizational capabilities, team members’ qualifications, or anything else that demonstrates competence in designing and executing the Protean program.

The composition of the team including relevant expertise should be included.

e) Tasking and Cost (0.5 page to 1 page): Provide a rough Order of Magnitude (ROM) for the total cost of the proposed solution with minimal, high-level instantiations of said cost.

Approximate tasks in bulleted form should be included in this section, with an approximate number of months assigned to each item. This cost can be given as a range.

f) Relevant References (does not contribute to page limit).

https://baa.darpa.mil/

3.3 ‘Gate 1’ Evaluation Criteria Gate 1 Video abstracts and Abbreviated Technical Volumes will be evaluated against criteria described below:

a) Technical Approach: Innovation of the approach relative to state of the art is well described.

Feasibility of the proposed approach to achieve the full scope of metrics and milestones of both Protean phases is considered. Risk mitigation strategies are provided where appropriate.

b) Technical Ability: The proposer demonstrates an ability, if selected, to achieve the goals of the Protean program, and the team comprises the expertise required to achieve program goals.

c) Relevance to the DARPA Mission: Proposed work is likely to provide value to the DoD and contribute to innovative solutions in chemical and biological defense.

d) Cost and Task Assessment: The tasks proposed are feasible to complete in the allotted time.

The set of tasks combine to achieve the milestones in the program. Cost (ROM) is realistic for the work proposed.

DARPA will provide selection letters to proposers who are deemed awardable by Gate 1 selection criteria. Selection letters will include instructions on how to submit a full proposal and outline key deadlines for remaining pre-award activities. NOTE: Proposers who are not selected at Gate 1 are ineligible to submit a full proposal.

3.4 ‘Gate 2’ Full Proposal Submission Information If DARPA requests a full proposal, the proposer will be asked to provide further details on its proposed solution. Specific instructions (including content submission guidelines and evaluation criteria) will be provided to the proposer in the invitation to participate.

Proposals will be evaluated by the Protean program manager with support from a panel composed of government subject matter experts (SMEs). After completing evaluation of full proposals, DARPA will: 1) inform the proposer of selection for negotiation, or 2) inform the proposer that its proposed concept/technology/solution is not selected and is no longer considered for participation in this program. If DARPA does not intend to issue an award for the effort to a proposer, DARPA may provide brief feedback to the proposer regarding the rationale for the decision.

3.5 General Guidelines

Do not include elaborate brochures or marketing materials; only include information relevant to the submission requirements or evaluation criteria.

Use of a diagram(s) or figure(s) to depict the essence of the proposed solution is encouraged.

All video abstracts and abbreviated technical volumes shall be no higher than CUI.

Proposers are responsible for clearly identifying proprietary information. Submissions containing proprietary information must have the cover page and each page containing such information clearly marked with a label such as “Proprietary” or “Company Proprietary.”

NOTE: “Confidential” is a classification marking used to control the dissemination of U.S.

Government National Security Information as dictated in Executive Order 13526 and should not be used to identify proprietary business information.

Questions can be sent to ProteanTherapeutics@darpa.mil by the due date on Page 3. A comprehensive list of questions and answers will be compiled, updated, and available online at https://www.darpa.mil/research/programs/protean.

Video abstracts and abbreviated technical volumes sent in response to this RA may be submitted via DARPA's BAA Website (https://baa.darpa.mil). Note: If an account has already been created for the DARPA BAA Website, this account may be reused. If no account currently exists for the DARPA BAA Website, visit the website to complete the two-step registration process. Submitters will need to register for an Extranet account (via the form at the URL listed above) and wait for two separate e-mails containing a username and temporary password. After accessing the Extranet, submitters may then create an account for the DARPA BAA website (via the "Register your Organization" link along the left side of the homepage), view submission instructions, and upload/finalize the proposal. Proposers using the DARPA BAA Website may encounter heavy traffic on the submission deadline date; proposers should start this process as early as possible.

All documentation submitted electronically through DARPA’s BAA Website must be uploaded as zip files (.zip or .zipx extension). The final zip file should be no greater than 100 MB in size. Only one zip file will be accepted per submission, and submissions not uploaded as zip files will be rejected by DARPA. Technical support for DARPA's BAA Website may be reached at BAAT_Support@darpa.mil, and is typically available during regular business hours (9:00 AM – 5:00 PM Eastern Time).

Submissions sent through other mediums or channels not described above or after the prescribed RA deadline will not be considered, reviewed, nor evaluated.

Proposers whose ‘video abstract’ and ‘abbreviated technical volume’ are not selected to submit a ‘full proposal’ will be notified in writing as soon as practicable.

4. Special Considerations

4.1 Proposal Information and Structure

Proposals submitted in response to Protean must be UNCLASSIFIED or CUI and must address all metrics outlined in section 2.3. The period of performance for this effort is 33 months. Specific technical objectives to be achieved, task descriptions, intellectual property rights, milestone payment schedules, and deliverables will be addressed according to the guidelines outlined in this

RA.

Proposers may only propose via a cooperative agreement or a Research OT with fixed payable milestones. All awards issued under this RA will be Other Transactions (Ots) awarded under the authority of 10 U.S.C. § 4021 or cooperative agreements under the authority of 10 U.S.C. § 4001.

The flexibility of the OT award instrument is beneficial to the program because the performer will be able to apply its best practices as required to carry out the research project that may be outside of the Federal Acquisition Regulation (FAR) process-driven requirements. Streamlined practices, mailto:ProteanTherapeutics@darpa.mil https://www.darpa.mil/research/programs/protean https://baa.darpa.mil/ mailto:BAAT_Support@darpa.mil such as milestone-driven performance measures, will be used and intended to reduce time and effort on award administration tasks and permit performers to focus on the research effort and rapid prototyping. OTs provide the Government and the proposer the flexibility to create an award instrument that contains terms and conditions that promote commercial transition, reduce some administratively burdensome acquisition regulations, and meet BTO program goals.

The Government will only award either a cooperative agreement or a Research OT agreement under this solicitation and will not consider any other award instruments. Refer to the model OT agreement provided as an attachment to this RA for additional information (Attachment 6 – Model Research Other Transaction (OT)). Specific milestones will be based on the Research Project Objectives detailed in the Research Announcement and Protean. No other negotiated changes to the OT terms and conditions and the cooperative agreement are expected. The milestone payments will be contingent on the proposed individual(s) continuing work on the proposed RA idea for the entire Period of Performance at their proposed level-of-effort (LOE).

Please see DARPA | Acquisition Innovation for more information on OTs and DARPA’s OT authority.

4.1.1 Cost Sharing/Matching

Cost sharing is not required; however, it will be carefully considered where there is an applicable statutory condition relating to the selected funding instrument (e.g., OTs under the authority of 10 U.S.C. § 4021). Cost sharing is encouraged where there is a reasonable probability of a potential commercial application related to the proposed research and development effort.

4.2 Intellectual Property (IP)/Data Rights

All proposers must provide a good faith representation that the proposer either owns or possesses the appropriate licensing rights to all intellectual property that will be utilized under the proposed effort.

If no restrictions are intended, the proposer should state “none.” The table below captures the requested information:

Technical Data Computer Software To be Furnished With Restrictions

Summary of Intended Use in the Conduct of the Research

Basis for Assertion

Asserted Rights Category

Name of Person Asserting

Restrictions

(LIST) (NARRATIVE) (LIST) (LIST) (LIST)

For All Non-Procurement Contracts Proposers responding to this RA requesting a Cooperative Agreement or Other Transaction for Prototypes shall follow the applicable rules and regulations governing these various award instruments, but, in all cases, should appropriately identify any potential restrictions on the Government’s use of any Intellectual Property contemplated under the award instrument in question. This includes both Noncommercial Items and Commercial Items.

Proposers are encouraged to use a format similar to that described in the section above. If no restrictions are intended, then the proposer should state “NONE.”

https://acquisitioninnovation.darpa.mil/

4.3 Program Security:

Protean will require performers to complete a Science & Technology Protection Implementation Plan (S&T PIP template included as Attachment 3) and implement it. Performers will provide a plan to safeguard all information, materials, and processes generated during the program relating to their intervention design product profile, particularly results on efficacy (in vitro or in vivo) and absorption, distribution, metabolism, and excretion (in vivo) as well as product profile information when associated with unclassified threat agents or simulants. Only proposers who are selected for full proposals will be asked to draft a S&T PIP. Performers are subject to controls outlined in the program-specific CUI guide, which provides a framework for identifying, protecting, and marking CUI in accordance with DoD policies and security classification guides. The scope of protection includes all aspects of the intervention design when associated with unclassified threat agents, including efficacy, pharmacokinetic and pharmacodynamics profiles. Throughout the program performers are encouraged to publish findings, however, all publications, external engagements, and investor discussions must be coordinated with DARPA and the Program Security Officer (PSO) to ensure compliance with CUI guidelines and export control regulations. Additionally, all publications must be submitted to DARPA's Public Release Center (DISTAR) for review and approval prior to public dissemination. All individuals accessing CUI information must complete approved training and ensure that sensitive information is safeguarded on systems compliant with NIST 800-171 standards. A detailed CUI guide is provided as an attachment to this solicitation as Attachment 4.

Proposers must describe credible approaches to complying with Protean's CUI guide. Performers will need to operate at the CUI level in accordance with the Protean's CUI Guide and DODI

5200.48. This includes providing a list of prospective individual researchers and their citizenship who will have access to CUI. Individuals with access to CUI must complete CUI training, agree to safeguard all CUI data, and submit manuscripts for review to DARPA prior to publications.

Performers will be responsible for ensuring their systems and research adhere to CUI standards (NIST 800-171) including but not limited to data analysis, storage, networking and data transfer, cloud, high-performance-computing (HPC), and document systems. Performers may provide their own CUI-certified systems, including laptops, desktops, cloud, HPC, etc. Solutions may include but are not limited to FedRAMP certified cloud services, local servers, etc. Proposed approaches must meet this requirement.

Further information on Controlled Unclassified Information identification, marking, protecting and control, to include processing on Non-DoD Information Systems, is incorporated herein and can be found at www.darpa.mil/work-with-us/additional-baa and the Protean CUI Guide. As Controlled Technical Information (CTI) is anticipated for this program, foreign proposers are encouraged to understand U.S. export law and have a plan in place to obtain export licenses when necessary. Possible methods include teaming with a U.S. prime and/or having a U.S.

subsidiary/parent company.

4.4 Additional Considerations:

This announcement, stated attachments, and websites incorporated by reference constitute the entire solicitation. In the event of a discrepancy between the announcement, attachments, or websites, the announcement takes precedence.

System for Award Management (SAM) Registration and Universal Identifier Requirements All proposers must be registered in SAM unless exempt per FAR 4.1102, FAR 52.204-7, “System for Award Management” and FAR 52.204-13, “System for Award Management Maintenance” are incorporated into this BAA. and have a valid Unique Entity ID to receive an award. All proposers must maintain an active and current SAM registration at all times throughout the award process, should they be selected. All proposers are to provide their Unique Entity ID in each proposal they submit. | Register in SAM International entities can register in SAM by following these instructions.

Content and Form of Application Submission All submissions, including abstracts, if applicable to your Broad Agency Announcement and proposals must be written in English with type not smaller than 12-point font. Smaller font may be used for figures, tables, and charts. All documents submitted must be clearly labeled with the DARPA BAA number, proposer organization, and proposal title/proposal short title.

All monetary references in the proposal shall be in U.S. Dollars.

Electronic Invoicing and Payments Awardees will be required to submit invoices for payment electronically via Wide Area Work Flow (WAWF), accessed through the Procurement Integrated Enterprise Environment, unless an exception applies. Registration in WAWF is required prior to any award.

Electronic and Information Technology All electronic and information technology acquired or created through a Broad Agency Announcement must satisfy the accessibility requirements of Section 508 of the Rehabilitation Act (29 U.S.C. § 749d) and FAR 39.2.

Patent Reports and Notifications All resultant awards will contain a mandatory requirement for patent reports and notifications to be submitted electronically through i-Edison.

Review of Proposals DARPA will conduct a scientific/technical review of each conforming proposal. Conforming proposals comply with all requirements detailed in this solicitation; proposals that fail to do so may be deemed non-conforming and may be removed from consideration. Proposals will not be evaluated against each other since they are not submitted in accordance with a common work statement. DARPA’s intent is to review proposals as soon as possible after they arrive;

however, proposals may be reviewed periodically for administrative reasons.

Award(s) will be made to proposers whose proposals are determined to be the most advantageous to the Government, consistent with instructions and evaluation criteria specified in the BAA herein, and availability of funding.

Handling of Source Selection Information DARPA policy is to treat all submissions as source selection information (see FAR 2.101 and 3.104), and to disclose their contents only for the purpose of evaluation. Restrictive notices notwithstanding, during the evaluation process, submissions may be handled by support https://sam.gov/SAM/ https://www.fsd.gov/sys_attachment.do?sys_id=c08b64ab1b4434109ac5ddb6bc4bcbb8 https://piee.eb.mil/ https://www.nist.gov/iedison contractors for administrative purposes and/or to assist with technical evaluation. All DARPA support contractors performing this role are expressly prohibited from performing DARPA-sponsored technical research and are bound by appropriate nondisclosure agreements. Subject to the restrictions set forth in FAR 37.203(d), input on technical aspects of the proposals may be solicited by DARPA from non-Government consultants/experts who are strictly bound by the appropriate non-disclosure requirements.

Award Information DARPA anticipates multiple awards. The level of funding for individual awards made under this BAA will depend on the quality of the proposals received and the availability of funds.

Awards will be made to proposers whose proposals are determined to be the most advantageous to the Government, all evaluation factors considered.

The Government reserves the right to:

o select for negotiation all, some, one, or none of the proposals received in response to this solicitation;

o make awards without discussions with proposers;

o conduct discussions with proposers if it is later determined to be necessary;

o segregate portions of resulting awards into pre-priced options;

o accept proposals in their entirety or select only portions of proposals for award;

o fund awards in increments with options for continued work at the end of one or more phases;

o request additional documentation once the award instrument has been determined (e.g., representations and certifications); and o remove proposers from award consideration should the parties fail to reach agreement on award terms within a reasonable time or the proposer fails to provide requested additional information in a timely manner.

In all cases, the Government contracting officer shall have sole discretion to select award instrument type, regardless of instrument type proposed, and to negotiate all instrument terms and conditions with selectees. DARPA will apply publication or other restrictions, as necessary, if it determines that the research resulting from the proposed effort will present a high likelihood of disclosing performance characteristics of military systems or manufacturing technologies that are unique and critical to defense. Any award resulting from such a determination will include a requirement for DARPA permission before publishing any information or results on the program. For more information on publication restrictions, see the section below on Public Restrictions on Non-Fundamental Research.

Proprietary Information Proposers are responsible for clearly identifying proprietary information. Submissions containing proprietary information must have the cover page and each page containing such information clearly marked with a label such as “Proprietary” or “Company Proprietary.”

NOTE: “Confidential” is a classification marking used to control the dissemination of U.S.

Government National Security Information as dictated in Executive Order 13526 and should not be used to identify proprietary business information.

Organizational Conflicts of Interest Proposers shall identify and disclose all facts relevant to potential Organizational Conflicts of Interest (OCI), involving the proposer’s organization, and any proposed team member (subawardee, consultant) in accordance with Federal Acquisition Regulation (FAR 9.5). The proposer is responsible for providing this disclosure with each proposal submitted to the solicitation. The disclosure must include the proposer’s, and as applicable, proposed team member’s OCI mitigation plan. The OCI mitigation plan must include a description of the actions the proposer has taken, or intends to take, to prevent the existence of conflicting roles that might bias the proposer’s judgment and to prevent the proposer from having unfair competitive advantage. The OCI mitigation plan will specifically discuss the disclosed OCI in the context of each of the OCI limitations outlined in FAR 9.505-1 through FAR 9.505-4.

Agency Supplemental OCI Policy In addition, DARPA has a supplemental OCI policy that prohibits contractors/performers from concurrently providing Scientific Engineering Technical Assistance (SETA), Advisory and Assistance Services (A&AS) or similar support services and being a technical performer.

Therefore, as part of the FAR 9.5 disclosure requirement above, a proposer must affirm whether the proposer or any proposed team member (subawardee, consultant) is providing SETA, A&AS, or similar support to any DARPA office(s) under: (a) a current award or subaward; or (b) a past award or subaward that ended within one calendar year prior to the proposal’s submission date.

If SETA, A&AS, or similar support is being or was provided to any DARPA office(s), the proposal must include:

o The name of the DARPA office receiving the support;

o The prime contract number;

o Identification of proposed team member (subawardee, consultant) providing the support; and o An OCI mitigation plan in accordance with FAR 9.5.

Government Procedures In accordance with FAR 9.503, 9.504 and 9.506, the Government will evaluate OCI mitigation plans to avoid, neutralize or mitigate potential OCI issues before award and to determine whether it is in the Government’s interest to grant a waiver. If the Government determines to grant a waiver, it will be processed after careful review of the mitigation plan. The Government will only evaluate OCI mitigation plans for proposals that are determined selectable under the solicitation evaluation criteria and funding availability.

The Government may require proposers to provide additional information to assist the Government in evaluating the proposer’s OCI mitigation plan.

If the Government determines that a proposer failed to fully disclose an OCI; or failed to provide the affirmation of DARPA support as described above; or failed to reasonably provide additional information requested by the Government to assist in evaluating the proposer’s OCI mitigation plan, the Government may reject the proposal and withdraw it from consideration for award.

Controlled Unclassified Information (CUI) on Non-DoD Information Systems Certain types of unclassified information require application of access and distribution controls and protective measures for a variety of reasons. This information is referred to collectively as Controlled Unclassified Information (CUI). DoD CUI is based on law, regulation, or government-wide policy. | DoD CUI Categories For further information, consult DoDI 5200.48, “Controlled Unclassified Information.”

All non-DoD entities doing business with DARPA are expected to adhere to the following procedural safeguards, in addition to any other relevant federal or DoD specific procedures, for submission of any proposals to DARPA and any potential business with DARPA:

Do not process DARPA CUI on publicly available computers or post DARPA CUI to publicly available webpages or websites that have access limited only by domain or Internet protocol restriction.

Ensure that all DARPA CUI is protected by a physical or electronic barrier when not under direct individual control of an authorized user and limit the transfer or DARPA CUI to subcontractors or teaming partners with a need to know and commitment to this level of protection.

Ensure that all DARPA CUI is only processed on information technology systems meeting NIST SP 800-171 or DoDI 8582.01 requirements.

Ensure that DARPA CUI on mobile computing devices is identified and encrypted and all communications on mobile devices or through wireless connections are protected and encrypted.

All wireless telephone transmission of CUI will be avoided when there are other options available.

Sanitize or destroy media containing CUI before disposal or release for reuse in accordance with NIST SP 800-88.

Proposers with questions regarding CUI should contact the DARPA Security and Intelligence Directorate at (703) 526-1581.

Publication Restrictions and Public Release Requirements for Non-Fundamental Research Per National Security Decision Directive (NSDD) 189, “fundamental research” is defined as basic and applied research in science and engineering, the results of which are ordinarily published and shared broadly within the scientific community. This contrasts with proprietary research and industrial development, where results are typically restricted for proprietary or national security reasons. Press releases or other marketing and publicity materials —including those related to fundamental research awards—are not considered results of fundamental research and are therefore subject to the publication review process that can be found here:

| Public Release When research conducted under an award is not considered fundamental research, the following publication restriction clause, or similar language, will apply:

“There shall be no dissemination or publication, except within and between the performer and any sub-awardees, of information developed under…